Kornimate/medical-research-clean huggingface dataset:
user acceptability evaluation of pseudophakic patients previously implanted with the tecnis odyssey iol

Conditions: Cataracts

Summary: prospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility criteria:
inclusion criteria: 1. previously bilaterally implanted with tecnis odyssey iol, following cataract extraction; 2. enrollment at least 21 days after second eye surgery; 3. clear intraocular media in each eye; 4. signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries; 5. availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures; 6. ability to understand, read, and write in english exclusion criteria: 1. concurrent participation in an interventional clinical trial during the time from which the data will be collected; 2. use of systemic or ocular medication that may affect vision 3. prior corneal refractive surgery in each eye (i.e., lasik, prk, smile, rk, ck); note: limbal relaxing incisions (lri) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits; 4. ongoing adverse events that might impact study measurements, as determined by the investigator; 5. acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.); 6. amblyopia, strabismus, nystagmus in each eye
efficacy of nutritional therapy with high methionine content in the treatment of nafld

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Summary: to assess the effect of a methionine metabolism-based dietary strategy in patients with non-alcoholic fatty liver disease in order to reduce complications while improving the quality of life for patients.

a randomized controlled clinical trial with parallel design was performed, a ratio of at least one patient in the control group for each subject in the experimental group.

Eligibility criteria:
inclusion criteria: • diagnosis of non-alcoholic fatty liver disease by biochemical parameters used by the steatotest and fatty liver index (ihg), greater than 60 points on the scale and confirmed by liver ultrasound exclusion criteria: • previous diagnosis of cirrhosis, hepatocarcinoma, wilson's disease, viral hepatitis b and c and neoplasms of any origin

Keywords: non-alcoholic fatty liver disease nutrition therapy randomized controlled trials
rabeprazole extended-release, 50 mg, versus esomeprazole, 40 mg, for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of rabeprazole extended-release (rab er) 50 mg versus esomeprazole (eso) 40 mg for the treatment of moderate to severe erosive gastroesophageal reflux disease (egerd).

this is a multicenter, randomized, double-blind, double-dummy, parallel-group study. subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended-release (rab er) 50 mg or esomeprazole (eso) 40 mg for the treatment of moderate to severe erosive gastroesophageal reflux disease (egerd).

Eligibility criteria:
key inclusion criteria: 1. male or female, ages 18 to 75 years. 2. history of gerd symptoms for at least 3 months immediately before screening. 3. heartburn for at least 2 days a week for at least 1 month before screening. 4. esophageal erosions of la grades c or d based on egd taken within 14 days prior to enrollment. 5. subjects who are h. pylori negative based on a screening test. 6. females should be either of non-childbearing potential or of childbearing potential. females of childbearing potential must have negative pregnancy tests prior to randomization. female subjects of childbearing potential must agree to use medically acceptable methods of contraception. 7. subjects must be able to read, write, and understand the language of the symptom diary. key exclusion criteria: 1. current or a history of esophageal motility disorders. 2. current or a history of barrett's esophagus. 3. current esophageal strictures or esophagitis (known or suspected to be due to etiology other than gerd such as infection or medications). 4. current or a history of zollinger-ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer. 5. current or a history of cancer, with the exception of fully excised skin basal cell carcinoma. 6. inflammatory bowel disease. 7. unstable diabetes mellitus. 8. history of esophageal, gastric and duodenal surgery except simple suturing of an ulcer. 9. subjects who require daily use of nonsteroidal anti-inflammatory drugs (nsaids), oral steroids (\>= 20 mg/day prednisone or equivalent), or aspirin (\> 325 mg/day).

Keywords: gerd erosive gerd erosive esophagitis
development and evaluation of a chlorhexidine gluconate bathing protocol for healthcare settings in low- and middle-income countries

Conditions: Multidrug Resistant Bacterial Infection

Summary: the overall goal of the chlorhexidine gluconate (chg) bathing protocol for healthcare settings in low- and middle-income countries (charm) study is to explore the safety, efficacy and feasibility of utilizing a locally prepared chg solution and bathing protocol among hospitalized neonates to reduce bacterial colonization and healthcare-associated infection (hai) burden in hospitalized patients.

neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south asia and sub-saharan africa, including botswana. multidrug-resistant organism (mdro) colonization is thought to precede infection, meaning that pathogens usually are transferred to the skin or intestinal mucosa where they live prior to translocating to the bloodstream or other sterile body compartments, triggering an inflammatory response recognized as clinical sepsis. colonization is established through direct or indirect contact between a patient and a reservoir that harbors the pathogen. multidisciplinary infection prevention and control (ipc) practices can reduce the risk of neonatal mdro colonization, but once colonized, newborns run the risk of acquiring a serious infection with a difficult-to-treat organism. the use of ancillary ipc measures, including chlorhexidine gluconate (chg) bathing, has been studied as a de-colonization measure among hospitalized patients. chg bathing is widely used in intensive care units (icus) across high-income countries to reduce bacterial colonization with pathogens, and is being used more frequently in neonatal units (nnus) in low and middle-income countries (lmics) as a sepsis prevention measure. the investigators of the charm study have developed a protocol to accomplish the following goals: 1. develop a low-cost, standardized protocol for chg bathing in the icu and nnu 2. assess safety of local chg preparation among hospitalized neonates 3. determine the efficacy of chg bathing using the developed protocol to reduce bacterial colonization and healthcare-associated infection (hai) burden in hospitalized patients 4. to assess the feasibility and acceptability of chg bathing among staff and caregivers the investigators will utilize a mixed methods study involving both a prospective interventional cohort study following approximately 240 neonates, and qualitative interviews of 10 caregivers and 20 healthcare workers in the nnu and icu.

Eligibility criteria:
inclusion criteria: * neonates 1-6 days old admitted to the neo-natal unit expected to stay at least 7 days exclusion criteria: * patients with a current weight of \<1kg * patients with a current corrected gestational age of \<28 weeks (by ballard score, or by dates if ballard is not done) * patients with a current diagnosis of hypothermia * patients with a current diagnosis of skin rash or skin injury
pre-operative very low-calorie protein-based versus hypocaloric enteral nutrition

Conditions: Perioperative/Postoperative Complications

Summary: pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. very-low-calorie diets (vlcds) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. therefore, the aim of the study is to investigate whether a vlcd results in lower intra-and post-operative complications compared to a hypocaloric diet. however, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. on the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. very-low-calorie diets (vlcds) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. therefore, the aim of the study is to investigate whether a vlcd results in lower intra-and post-operative complications compared to a hypocaloric diet. however, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Eligibility criteria:
inclusion criteria: * patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation * availability to long-term post-operative follow-up * normal kidney function serum creatinine ≤ 1,2 mg/dl and glomerular filtration rate ≥ 90 ml/min * normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase \< 2 x n) * written informed consent exclusion criteria: * age \ 60 anni * serum creatinine \>1,2 mg/dl * liver failure (child-pugh ≥ a) * insuline-dependent diabetes mellitus * atrioventricular block with qt \> 0,44 ms * cardiac arrythmias * moderate-severe cardiac failure * hypokaliemia * chronic diarrhoea or vomitus * 12-month previous cardio-vascular disease * pregnancy and/or lactation * current/previous neoplastic disease * psychiatric disorders * know gastro-intestinal diseases * other controindications to enteral nutrition * moderate-severe hypo-albuminemia (\<3.0 mg/dl) * 6-month previous diet-induced weight loss * intragastric balloon * unavailability to planned measurements
carotid revascularization with ev3 arterial technology evolution (create) trial

Conditions: Carotid Artery Disease

Summary: evaluate the safety and efficacy of the protege stent and spider device in the treatment of common and/or internal carotid artery stenoses for subjects that are high risk for carotid endarterectomy.


Eligibility criteria:
inclusion criteria: * 18 years and above * informed consent * for female subjects, not pregnant or planning on becoming pregnant * meet protocol defined anatomical or clinical high risk criteria exclusion criteria: * participation in another clincial study which may affect either the pre-procedure or follow-up results * prior stenting of the ipsilateral carotid artery * life expectancy less than twelve months * known allergy or intolerance of study medications or device materials * must not meet general or angiographic exclusion criteria as defined in the protocol

Keywords: carotid artery disease embolic protection
effect of intravitreal bevacizumab on early post-vitrectomy hemorrhage in diabetic patients

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

diabetes is the leading cause of blindness in the age range of 20-64 years. pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. this may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. preliminary reports such as case series reported by spaide rf, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

Eligibility criteria:
inclusion criteria: * all eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive pdr exclusion criteria: * one eye patient * best corrected visual acuity better than 20/50 * pregnancy * use of internal tamponade such as silicone oil during surgery * concurrent ophthalmic surgery such as cataract extraction

Keywords: proliferative diabetic retinopathy bevacizumab early post-vitrectomy vitreous hemorrhage
combined oral vitamin d and uvb versus uvb alone in treatment of psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: to compare the results of vitamin d plus uvb in treatment of psoriasis vulgaris with the results of uvb alone to study the relation between serum vitamin d and pasi score before and after treatment.

psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. the primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs . vitamin d, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . the epidermis is the natural source of vitamin d synthesis by the action of ultraviolet light (uv) b of the sun or other uvb source . on the other hand, evidence is accumulating that vitamin d might represent a key modulator of immune and inflammation mechanisms . recently, a role for vitamin d in the pathogenesis of different skin diseases, including psoriasis, has been reported. psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . psoriasis area and severity index (pasi) score is currently the preferred method for the assessment of the disease severity and extent . physiologically, the active form of vitamin d and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis. several studies identified an association between polymorphisms of vitamin d receptor (vdr) and psoriasis susceptibility .the 1,25(oh)d has been shown to exert anti-proliferative effects on keratinocytes . the exact mechanism of action of nbuvb is not known. it is proposed that it acts in the following ways: (1) cellular dna is converted to pyrimidine dimers which interfere with cell cycle progression, (2) alteration in cytokine production, nbuvb phototherapy as the second-line treatment for psoriasis, recommended when the topical therapy fails, is contraindicated or impractical. uvb radia- tions of wavelength 311 nm may result in the clearance of disease symptoms after just 5-8 weeks.

Eligibility criteria:
inclusion criteria: * : patients from 10 to 60 diagnosed to have psoriasis vulgaris exclusion criteria: 1. concomitant chronic inflammatory disease or malignancy. 2. pregnant and lactating women. 3. renal dysfunction.
low level laser versus neural mobilization of brachial plexus on shoulder dysfunction post liver donation

Conditions: Shoulder Pain

Summary: the purpose of the study will be to compare therapeutic effect of low level laser versus neural mobilization techniques on shoulder dysfunction post liver donation.

the need for this study develops from the lack of information in the published studies about the effectiveness of low level laser and neural mobilization of brachial plexus on shoulder dysfunction post liver donation. following liver donation and transplantation, shoulder dysfunction and discomfort occur in 20% to 60% of patients. low-level laser therapy (lllt) has been used as a non-pharmacological alternative to treat painful musculoskeletal conditions. it is used in acute, chronic painful and inflammatory affections shows that low energy irradiation from lasers alters cellular processes, producing anti-inflammatory effects and increased collagen turnover. neural mobilization (nm) is an intervention aimed at restoring the homeostasis in and around the nervous system, by mobilization of the nervous system itself or the structures that surround the nervous system. neural mobilization facilitates movement between neural structures and their surroundings (interface) through manual techniques or exercise. human and animal studies revealed that nm reduces intraneural edema, improves intraneural fluid dispersion, reduces thermal and mechanical hyperalgesia and reverses the increased immune responses. the present study is designed to investigate the effect of lllt versus nmt on shoulder dysfunction post liver donation.

Eligibility criteria:
inclusion criteria: * patients are both males and females. * their age will range from (20-50) years. * patients will suffer from unilateral shoulder pain(rt shoulder). * patients will begin the training program one week post.operative. * all patients will suffer from moderate to severe pain (vas score \> 4). * patients will be given their informed consent. exclusion criteria: * known history of high level spinal cord injury and malignancy * metabolic disease with a neurological component such as diabetes. * orthopedic disorders such as fracture or dislocation. * musculoskeletal disorders that will impair performance during training and tests. * uncontrolled cardiovascular or pulmonary diseases . * circulatory disturbances of upper extremity * psychiatric illness, severe behavior or cognitive disorders. * uncooperative patients.
effects of pioglitazone in calcific aortic valve disease

Conditions: Calcification of Aortic Valve; Aortic Valve Stenosis

Summary: this is a prospective, randomized, comparative, clinical trial conducted by wuhan union hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.

pioglitazone is an oral drug for the treatment of type 2 diabetes that improves the utilization of glucose by the body by inhibiting hepatic gluconeogenesis, and has anti-inflammatory and antioxidant effects that may improve vascular endothelial cell injury and prevent cardiovascular disease. this study is to slow the process of aortic valve calcification by pioglitazone intervention with the aim of reducing the risk of aortic valve stenosis. participants were randomized into two groups: one group was given oral pioglitazone treatment and the other group was given placebo control. patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.

Eligibility criteria:
inclusion criteria: * male or female adult ≥ 35 years of age at the time of rescruiting. * subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by doppler echocardiography results: aortic valve mean pressure gradient between 10-30 mmhg and aortic valve area ≥ 1.2 and ≤ 2.0 cm2 on tte within 2 weeks prior to randomization and cardiac compute tomography (ct) test results: aortic valve calcium score (agatston score) ≥ 200 au at baseline cardiac ct within 1 month prior to randomization * subject provides written informed consent prior to initiation of any study procedures. * subject understands and agrees to comply with planned study procedures. exclusion criteria: * subject has concomitant moderate or severe mitral or tricuspid valve disease. * subject has left ventricular ejection fraction \< 50%. * subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse. * subjects whose alanine aminotransferase (alt) and aspartate aminotransferase (ast) \> 2.5 times the upper limit of normal range. * subjects who cannot undergo cardiac ct. * pregnant or lactating women. * consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.

Keywords: calcification of aortic valve aortic valve stenosis pioglitazone
point of care lung ultrasound in preterm infants with respiratory distress

Conditions: Bronchopulmonary Dysplasia

Summary: the goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems. the main question this study aims to answer is: can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants?

this is a multicenter study including preterm infants born less than 32 weeks gestational age and with a diagnosis of respiratory distress syndrome (rds). our primary aim is to determine the ability of lung ultrasounds performed in the first month of life to predict the development of bronchopulmonary dysplasia (bpd) at 36 weeks postmenstrual age. secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus (pda) at time of diagnosis, as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course. hypothesis: 1. lus scores would have a predictive ability to identify extreme preterm infants at risk of bpd with auc\>0.8. 2. higher lus scores would correlate with higher severity of hemodynamically significant pda. 3. lus scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids.

Eligibility criteria:
inclusion criteria: infants born less than 32 weeks gestation and meet one or more of the below criteria a) diagnosis of respiratory distress syndrome b) diagnosis of pda c) post-natal steroid treatment for the purpose of weaning off ventilation support exclusion criteria: infants with critical congenital heart and lung conditions and those with genetic anomalies.

Keywords: lung ultrasound bpd bronchopulmonary dysplasia